Bulking agent compositions

ABSTRACT

The present invention provides an ingestible composition comprising a fibre or sacharide bulking agent, an ingestible silica, and at ingestible surfactant. The provision of the silica and the surfactant provides a synergistic benefit in the dispersal of the bulking agent in water thus making if easier and/or quicker to obtain an imbibable liquid. The bulking agent may be ispaghula, a natural material of benefit in promoting good bowel function.

The present invention relates to medicinal compositions comprising fibrebulking agents.

Ingestible fibre-compositions for the relief of gastric and digestivedysfunctions are known Examples of such compositions include granularpsyllium husk fibre (ispaghula) intended to be stirred in measuredamounts into a volume of liquid, usually water or soft drinks. Afterstirring, the drinking composition is intended to be quickly imbibed dueto the propensity of the ispaghula to absorb water readily and swell toform a viscous gel-like mass. It is the property of water absorptionwhich has the desired characteristic of fibre or saccharide-containingingestible compositions for gastric and digestive dysfunctions. Once thefibre or saccharide-containing composition has absorbed water to producethe gel-like mass, the mass is relatively insoluble and fibrous, and istransported through the gut quickly with minimal digestion, helping toalleviate constipation and other digestive dysfunctions.

Other forms, such as capsules forms for ingestion, are also available,such capsules being designed to be broken down in the gut, wherein thereleased fibre or saccharide bulking agent absorbs water from the gut toform the viscous mass.

However, for beneficial ease-of-use properties, a particulate form isparticularly advantageous to the end user, as this can be stirred into avolume of liquid, for a more pleasant taste, and the granular form ofthe fibre absorbs water from the gut more quickly than a capsule form.However, there are a number of problems involved in using a granularform of the fibre-containing ingestible compositions.

Primarily, it is desirable for the ingestible compositions to disperseeasily in liquid, for the user's convenience and/or so that theresultant drink is more palatable and/or easier to swallow. Any newcomposition must be as good as or, preferably, better than, existingcompositions in this respect.

Secondly, the handling of some ingestible fibre-containing compositionsis not straightforward. For example in commercial production ispaghulais milled then isopropyl alcohol and a granulating agent polyvinylpyrollidone are added. These steps aid handling of the compositionsduring manufacturing, before the isopropyl alcohol is removed prior topackaging the product for sale. The granulation also aids the dispersionof the ispaghula into a volume of liquid, prior to ingestion. However,the use of the granulating agent and isopropyl alcohol increases thecost of production and the use of the isopropyl alcohol is undesirablefrom an environmental and a health and safety perspective.

Thus, from the foregoing, it is apparent that there is a need for theprovision of an ingestible composition which comprises a fibre bulkingagent, in which the ingestible composition disperses easily in anaqueous liquid and/or is of improved manufacture.

It has now been determined that an ingestible composition comprising apsyllium husk fibre bulking agent (ispaghula) colloidal silica inconjunction with an ingestible surfactant, can offer benefit in themanufacture of the ingestible composition, and can increase the rate atwhich the ingestible composition disperses in water or other ingestibleliquid.

Therefore, according to the present invention there is pr vided aningestible composition comprising ispaghula, colloidal silica and aningestible surfactant wherein said composition is in a form so that inuse it is dispersed in a liquid prior to ingestion.

The presence of both an ingestible silica and an ingestible surfactantcan confer significant, eg Synergistic, benefits. For example, theternary composition of the ispaghula has outstanding wettabilityproperties, and is easy to manufacture, for example by simple blending.

Suitably the fibre bulking agent is a natural ingestible fibre (by whichterm we include herein fibre extracts) Plant-derived fibre bulkingagents from psyllium husk fibre (ispaghula) are used.

The ispaghula may comprise whole ispaghula seeds, but preferably atleast part of the ispaghula comprises separated ispaghula seed husks.More preferably the ispaghula comprises at least 50% wt separatedispaghula husks, most preferably at least 95% wt separated ispaghulahusks. Suitably the remainder of the ispaghula comprises other seedparts and/or other ispaghula plant materials. In preferred compositionsthe seed kernels themselves have been substantially removed to leave thehusks.

Suitably the fibre bulking agent is present in the ingestiblecomposition in an amount of at least 10 wt %, preferably at least 30 wt%, and most preferably at least 40 wt % of the total weight of theingestible Composition.

Suitably the fibre bulking agent is present in the ingestiblecomposition in an amount up to 90 wt %, preferably up to 80 wt %, andmost preferably up to 75 wt % of the total weight of the ingestiblecomposition.

Suitably the colloidal silica is fumed or precipitated synthetic ornatural silica. The silica may be amorphous or crystalline.

Suitably the mean particle size of the silica is at least 5 nm,preferably at least 10 nm.

Suitably the mean particle size of the silica is up to spm, preferablyup to 0.75 μm, more preferably up to 0.5 μm, and most preferably up to0.2 μm.

One suitable silica material is Syloid 244 which is amorphous silica,has a mean particle size of about 3 μm and is provided by W R Grace &Co. Another suitable silica materials is Silox 15, also from W R Grace &Co., and which has a mean particle size of about 4 μm.

Another suitable silica material is Huber Zep 49 which is amorphoussilica from J M Huber Corporation and contains about 1 wt % alumina.

Another suitable silica is Aerosil 200 from Degussa Company. It containsless than 0.05 wt % alumina and has a mean particle size of 12 nm.

The silica is colloidal silica (silicon dioxide), and a preferred silicais a colloidal silica which is sold under the trade mark CAB-O-SIL, byCabot Inc, USA.

Suitably the specific surface area of the silica is at least 50 m² g⁻¹,preferably at least 150 m² g⁻¹.

Suitably the specific surface area of the silica is up to 400 m² g⁻¹,preferably up to 300 m² g⁻¹ most preferably up to 200 m² g⁻¹.

Suitably the silica is present in the ingestible composition in anamount at least 0.01 wt %, preferably at least 0.05 wt %, morepreferably at least 0.1 wt % and most preferably at least 0.25 wt %, ofthe total weight of the ingestible composition.

The upper limit of silica in the ingestible composition may be up to 11wt %. Suitably the silica may be present in the ingestible compositionin an amount up to 5 wt %, preferably up to 2 wt %, more preferably upto 1 wt %, and most preferably up to 0.6 wt %, of the total weight ofthe ingestible composition.

Preferably the ingestible surfactant is a polyethylene-, polypropylene-,or polyoxyethylene-based surfactant. Suitable polyethylene orpolyoxyethylene-based surfactants include polyethylene glycols andpolyoxyethylene sorbitan fatty acid esters (polysorbates).

Suitable polyethylene glycols have a molecular weight of between 200 and40,000, preferably between 200 and 1,000, and more preferably between200 and 600. Suitable polyethylene glycols include MACROGOLD andMACROGOLUM polyethylene glycols sold by ICI Surfactants, UK. Othersuitable surfactants include polyoxyethylene monostearates and glycerolpolyethylene glycol oxystearates.

Suitably the surfactant is present in the ingestible composition in anamount at least 0.01 wt %, preferably at least 0.05 wt %, morepreferably at least 0.1 wt %, and most preferably at least 0.2 wt %, ofthe total weight of the ingestible composition.

Suitably the surfactant is present in the ingestible composition in anamount up to 5 wt %, preferably up to 3 wt %, more preferably up to 2 wt% and most preferably up to 1 wt %, of the total weight of theingestible composition.

When the surfactant is polyethylene glycol it is preferably present isan amount at least 0.1 wt %, more preferably at least 0.3 wt %, of thetotal weight of the ingestible composition.

When the surfactant is polyethylene glycol it is preferably present isan amount up to 2 wt %, more preferably up to 1.5 wt %, of the totalweight of the ingestible composition.

When the surfactant is a polyoxyethylene sorbitan fatty acid ester it ispreferably present in an amount at least 0.01 wt %, more preferably atleast 0.05 wt %, and most preferably at least 0.08 wt %, of the totalweight of the ingestible composition.

When the surfactant is a polyoxyethylene sorbitan fatty acid ester it ispreferably present in an amount up to 2 wt %, more preferably up to 1 wt%, and most preferably up to 0.5 wt %, of the total weight of theingestible composition.

The percentages stated represent the total complement of the silica andsurfactant, that is, summated if there is more than one silica orsurfactant in the composition.

The ingestible composition may further comprise ingestibleco-ingredients such as a bicarbonate for example sodium bicarbonate, aningestible acid, for example citric acid, a flavouring, or a colouring,for example.

Preferably the ingestible composition does not contain a granulatingagent.

Most preferably the ingestible composition does not contain polyvinylpyrollidone.

Preferably the ingestible composition does not contain any residue ofpolyvinyl alcohol.

The composition is particularly preferred in a form such that it iseasily dispersed in a liquid such as water before drinking. Suitably thecomposition is provided in a particulate or granular solid form, forexample as a powder or flakes, intended to be mixed with water, prior toingestion by a user. Alternatively the composition may be provided as acapsule for dispersal in a liquid, for drinking by a user. Preferablythe composition is provided in a particulate form.

In accordance with a second aspect of the present invention there isprovided a method of making an ingestible composition comprising a fibreor saccharide bulking agent, an ingestible silica, and an ingestiblesurfactant, the method comprising the step of blending the fibre orsaccharide bulking agent with the ingestible silica and the ingestiblesurfactant.

Preferably no isopropyl alcohol is used in the manufacture.

More preferably no solvent of any type is used in the manufacture.

Preferably no polyvinyl pyrollidone is used in the manufacture.

More preferably no granulating agent of any type is used in themanufacture.

The fibre or saccharide bulking agent may be milled prior to theblending step, suitably to a mean particle size in the range 250-450 μm.

Preferably the method does not include the granulation of the bulkingagent.

The fibre or saccharide bulking agent may be subjected to asterilization step prior to the blending step. Irradiation may employsteam or, preferably, a radioactive source, for example a y-radiationsource, for example from a Cobalt-60 or Caesium-137 source. A suitableradiation dosage is up to 13 kGy, preferably 5-10 kGy.

The invention will now be described by way of example in which thefollowing materials are used throughout:

Ispaghula—Ispaghula husk material obtained from Plantago ovata, brokendown to enable the seed kernels to be removed. The material was dried,irradiated with γ-radiation from a Caesium-137 source at a dosage rateof about 7 kGy, as described in PCT/GB01/02040, and milled to a meanparticle size of 300-400 μm.

CAB-O-SIL (Trade Mark)—A colloidal silica having a specific surface areain the range 175-225 m² g⁻¹ manufactured by Cabot Inc, USA.

TWEEN 60 (Trade Mark)—A polyoxyethylene sorbitan fatty acid ester,manufactured by ICI.

TWEEN 80 (Trade Mark)—A polyoxyethylene sorbitan fatty acid ester,manufactured by ICI.

Propylene glycol.

Cremophore RH40—Glycerol polyethylene glycol oxysterate, manufactured byBASF.

Pricerine—Porcine glyerine, supplied by Uniquema.

PEG 200—Polyethylene glycol, molecular weight approximately 200,manufactured by Clariant.

Liquid surfactants were added slowly to the ispaghula as it was beingmixed in a domestic-style MAGIMIXER (Trade Mark). Mixing was continueduntil the ispaghula appeared evenly covered (dampened).

Solid surfactants were ground in a pestle and mortar and then added tothe ispaghula and placed in an oven (60-70° C.) for 30 minutes. Thesamples were then quickly blended in the MAGIMIXER as above.

To the ispaghula blended with surfactant as described above was added acolloidal silica sample (CAB-O-SIL) in an attempt to dust the samplesdry and improve flow characteristics (but also—as will be seen—with theunexpected result that the wetting characteristics of the final productwere greatly improved).

No granulation step took place; no granulating agent was used.

Test Methods

1. Wettability (Dispersion in Water)

This was the most important test used to assess the effectiveness ofeach treatment and simply involved slowly spreading an amount of theformulation containing 3.5 g ispaghula onto the surface of 150 ml ofcold tap water contained in a 200 ml Pyrex beaker, and recording thetime taken for all the material to become fully wetted without using anyagitation to quicken the process.

2. Water Absorbency/Swell Volume

This test determines the swell volume (ml) or ability of a product totake up water. This is a key property for the mechanism of action ofispaghula, and hence disruption/reduction to this effect would certainlyimpact on efficiency.

The method is as follows:

Add 1 g of ispaghula (or the equivalent wt of product containing 1 gispaghula) to 100 ml of tap water in a 100 ml measuring cylinder, mixthoroughly by shaking and allow to stand. At 1 and 2 hours mix again bygentle inversion, and allow to stand for a further 2 hours. At the endof this period (4 hours from start), record the level of mucilage/gel inthe measuring cylinder. Typically, this will be 40-50 ml per gramme ofispaghula.

3. Gel/Flow Rate on Hydration

This method is used to gain an insight into the rate of gel/mucilageformation. Although gelling is an important attribute, the initial onsethas been delayed in ingestible ispaghula compositions to allow theconsumer to ingest it, over a period of a few minutes, as a palatabledrink.

A weight of sample containing 3.5 g ispaghula is mixed into 150 ml coldtap water in a 200 ml beaker. At 5 minute intervals after making up, thetime taken for 100 ml of the sample to run through a Flow Cup (No. 5)viscometer is recorded. This is basically a brass cup which holdsexactly 100 ml, with a tapered bottom leading to a standard-sized hole.As a sample gels, then the time taken for 100 ml to flow throughincreases.

4. Carr's Index

Carr's index is a measurement of bulk density of pharmaceutical powders,measured in a Copley Erweka Tapped Volumeter, model SVM-22. Powder isplaced in a vertical cylinder which is “tapped” in the machine to aidthe settlement of the powder, and the percentage change in volumemeasured, over the predetermined test period/regime, identical for eachsample.

EXAMPLE 1

In this series of tests the wetting ability of ternary ispaghula+PEG200+CAB-O-SIL compositions was assessed, and coqcpaired with non-ternarycompositions. The wettability was measured after 5 minutes, 16-24 hoursand 8 days; there is reason from work on other compositions to believethat wettability can decrease as the interval from manufactureincreases.

As will be seen, there were three replicates. All three results aregiven in Tables 1-3 below.

In each test the measurement was of time (secs) for a dose of treatedispaghula (3.5 g) to disperse.

Tables 1-3

PEG 200+CAB-O-SIL 5 Mins After Manufacture CAB-O-SIL PEG 200 levels (wt%) levels (wt %) 0.3 0.5 0.4 5, 5, 5 7, 5, 6 0.8 7, 8, 7 6, 5, 5 1.2 6,4, 4 6, 7, 7Comparisons:

-   -   no PEG 200, no CAB-O-SIL: 270, 310, 330    -   no PEG 200, 0.3 wt % CAB-O-SIL: 165, 170, 165    -   0.4 wt % PEG 200, no CAB-O-SIL: 120, 130, 135

PEG 200+CAB-O-SIL 16-24 Hours After Manufacture CAB-O-SIL PEG 200 levels(wt %) levels (wt %) 0.3 0.5 0.4 6, 6, 6 7, 5, 7 0.8 20, 20, 20 6, 5, 61.2 11, 12, 11 12, 11, 12Comparisons:

-   -   no PEG 200, no CAB-O-SIL: not measured    -   no PEG 200, 0.3 wt % CAB-O-SIL: 330, 330, 350    -   0.4 wt % PEG 200, no CAB-O-SIL: 305, 320, 320

PEG 200+CAB-O-SIL 8 Days After Manufacture CAB-O-SIL PEG 200 levels (wt%) levels (wt %) 0.3 0.5 0.4 11, 12, 11 10, 6, 7 0.8 25, 25, 30 8, 8, 81.2 22, 30, 26 15, 17, 15Comparisons:

-   -   no PEG 200, no CAB-O-SIL: 310, 300, 280    -   no PEG 200, 0.3 wt % CAB-O-SIL: 1800, 1200, 1740    -   0.4 wt % PEG 200, no CAB-O-SIL: 470, 480, 510

EXAMPLE 2

This series of tests were as Example 1, but used TWEEN 80 instead of PEG200, and different time intervals. In these tests ispaghula alone wasnot tested. The results are given in Tables 4-6 below. Again, in eachtest the measurement was of time (secs) for a dose of treated ispaghula(3.5 g) to disperse (n=3).

Tables 4-6

TWEEN 80+CAB-O-SIL 5 Mins After Manufacture CAB-O-SIL TWEEN 80 levels(wt %) levels (wt %) 0.3 0.5 0.09 21, 16, 17 20, 17, 20 0.14 7, 7, 8 8,5, 8 0.20 4, 4, 5 4, 4, 4Comparisons:

-   -   no TWEEN 80, no CAB-O-SIL: not measured    -   no TWEEN 80, 0.3 wt % CAB-O-SIL: 180, 215, 225    -   0.09 wt % TWEEN 80, no CAB-O-SIL: 75, 80, 75

TWEEN 80+CAB-O-SIL 72 Hours After Manufacture CAB-O-SIL TWEEN 80 levels(wt %) levels (wt %) 0.3 0.5 0.09 25, 25, 30 30, 22, 25 0.14 10, 13, 1110, 10, 9 0.20 6, 5, 4 4, 5, 5Comparisons:

-   -   no TWEEN 80, no CAB-O-SIL: not measured    -   no TWEEN 80, 0.3 wt % CAB-O-SIL: 495, 450, 480    -   0.09 wt % TWEEN 80, no CAB-O-SIL: 63, 70, 60

TWEEN 80+CAB-O-SIL 7 Days After Manufacture CAB-O-SIL TWEEN 80 levels(wt %) levels (wt %) 0.3 0.5 0.09 36, 27, 32 35, 35, 35 0.14 10, 10, 1210, 9, 8 0.20 7, 7, 6 4, 5, 5Comparisons:

-   -   no TWEEN 80, no CAB-O-SIL: not measured    -   no TWEEN 80, 0.3 wt % CAB-O-SIL: 735, 795, 930    -   0.09 wt % TWEEN 80, no CAB-O-SIL: 75, 67, 7

Again the results for the ternary system are remarkable, much betterthan either binary system.

EXAMPLE 3

This test was used primarily to assess long term is wettabilityproperties. Obviously such properties are extremely important for acommercial product.

As before, each experiment employed 3.5 g of ispaghula in thecomposition, except that for the swell volume test 1 g of compositionwas used.

The compositions were placed in a cycling oven, cycling between 4° C.and 30° C. The samples were tested immediately on preparation, after 5weeks incubation in the cycling oven, and after 3 months incubation thecycling oven. As an exception, compositions including CAB-O-SIL and PEG200 were tested immediately and after 9 weeks incubation only. Theresults of the experiment are shown in Table 7. TABLE 7 Storageconditions - Cycling Oven (4° C./30° C.) Initial samples 5 week samplesSwell Flow cup Swell Swell Flow cup Carrs Vol Wettability after VolWettability Flow cup Vol Wettability after Index (ml) times 15 min (ml)times after 15 min (ml) times 15 min Composition (n = 2) (n = 2) (secs)(secs) (n = 2) (secs) (secs) (n = 2) (secs) (secs) 3 month samplesUntreated 270 Ispaghula +0.16 wt % TWEEN 9 40 23 45 44 19 35 37 19 6180 + 0.08 wt % CAB- O-SIL +0.16 wt % TWEEN 9 40 20 25 44 19 52 42 22 5260 + 0.08 wt % CAB- O-SIL +0.4 wt % 6 40 44 25 44 60 18 43 81 59Propylene glycol + 0.08 wt % CAB-O-SIL +1.2 wt % 7 40 25 25 41 19 33 4432 46 Cremophore + 0.24 wt % CAB-O-SIL +0.4 wt % 7 41.5 50 35 45 120 2141 211 62 Pricerine + 0.4 wt % CAB-O-SIL 9 weeks storage +0.56 wt % PEG200 + 9 41 15 35 47 27 48 0.24 wt % CAB-O-SIL

The results show that the addition of all of the tested combinations ofingestible silica in combination with an ingestible surfactant,substantially reduces the time taken for the ispaghula to disperse in a150 ml beaker of cold water (wettability). The wettability time issignificantly reduced on initial testing and remains reduced through the5 week samples and the 3 month samples.

In particular, polyethylene glycol and TWEEN in combination withCAB-O-SIL show a marked ability to reduce the wettability time ofuntreated ispaghula husk compared to other combinations of surfactantwith CAB-O-SIL. The results therefore indicate that ingestiblecompositions comprising surfactant plus CAB-O-SIL mixed with ispaghulahusk are also shelf stable at ambient temperatures (between 4° C. and30° C.) over a sustained period of time.

EXAMPLE 4

The tests corresponded to those of Example 3 but the compositions weretested by incubating at 40° C. in an incubating oven. The samples weretested immediately on preparation, after 5 weeks incubation and after 3months incubation. As an exception, compositions containing CAB-O-SILand PEG 200 were tested immediately and after 9 weeks incubation only.The results of the experiment are shown in Table 8. TABLE 8 Storageconditions: 40° C. Initial samples 5 week samples Swell Flow cup SwellSwell Flow cup Carrs Vol Wettability after Vol Wettability Flow cup VolWettability after Index (ml) times 15 min (ml) times after 15 min (ml)times 15 min Composition (n = 2) (n = 2) (secs) (secs) (n = 2) (secs)(secs) (n = 2) (secs) (secs) 3 month samples Untreated 270 Ispaghula+0.16 wt % TWEEN 9 40 23 45 44 20 18 46 17 40 80 + 0.08 wt % CAB- O-SIL+0.16 wt % TWEEN 9 40 20 25 44 22 21 50 16 31 60 + 0.08 wt % CAB- O-SIL+0.4 wt % 6 40 44 25 42 85 23 47 110 28 Propylene glycol + 0.08 wt %CAB-O-SIL +1.2 wt % 7 40 25 25 41 20 45 37 26 30 Cremophore + 0.24 wt %CAB-O-SIL +0.4 wt % 7 41.5 50 35 43 180 35 50 364 41 Pricerine + 0.4 wt% CAB-O-SIL 9 weeks storage +0.56 wt % PEG 200 + 9 41 15 35 47 26 230.24 wt % CAB-O-SIL

1. An ingestible composition comprising ispaghula, colloidal silica, andan ingestible surfactant wherein said composition is in a form so thatin use it is dispersed in a liquid prior to ingestion.
 2. An ingestiblecomposition according to claim 1 wherein said composition in particulateor granular form.
 3. An ingestible composition according to claim 1wherein the particle size of the silica is between 5 nm and 5 μm.
 4. Aningestible composition according to claim 1 wherein the specific surfacearea of the silica is between 50 and 400 gm⁻².
 5. An ingestiblecomposition according to claim 1 wherein the silica is present in anamount of between 0.01 wt % and 5 wt % of the total weight of theingestible composition.
 6. An ingestible composition according to claim1, wherein the ingestible surfactant is a polyethylene-, polypropylene-,or polyoxyethylene-based surfactant.
 7. An ingestible compositionaccording to claim 6 wherein the polyethylene-based surfactant is apolyethylene glycol.
 8. An ingestible composition according to claim 1wherein the polyethylene glycol has a molecular weight of between 200and 40,000.
 9. An ingestible composition according to claim 6 whereinthe polyoxyethylene-based surfactant is a polyoxyethylene sorbitan fattyacid ester.
 10. An ingestible composition according to claim 6, whereinthe surfactant is a polyoxyethylene monostearate or a glycerolpolyethylene glycol oxystearate.
 11. An ingestible composition accordingto claim 1 wherein the ingestible surfactant is present in an amount ofbetween 0.01 wt % and 5 wt % of the total weight of the ingestiblecomposition.
 12. An ingestible composition according to claim 11 whereinthe ingestible surfactant is polyethylene glycol and is present in anamount of between 0.1 wt % and 2 wt % of the total weight of theingestible composition.
 13. An ingestible composition according to claim11 wherein the surfactant is a polyoxyethylene sorbitan fatty acid esterand is present in an amount of between 1 wt % and 2 wt % of the totalweight of the ingestible composition.
 14. A method of making aningestible composition comprising ispaghula, colloidal silica, and aningestible surfactant, the method comprising the step of blending theispaghula with the colloidal silica and the ingestible surfactant. 15.An ingestible composition or its manufacture substantially as describedherein.
 16. A method according to claim 14, of making an ingestiblecomposition comprising ispaghula, colloidal silica, and an ingestiblesurfactant, the method comprising the step of blending the ispaghulawith the colloidal silica and the ingestible surfactant preferablywithout the employment of any solvent.
 17. A method according to claim16, of making an ingestible composition comprising ispaghula, colloidalsilica, and an ingestible surfactant, the method comprising the step ofblending the ispaghula with the colloidal silica and the ingestiblesurfactant preferably without the employment of isopropyl alcohol.
 18. Amethod according to claim 14, of making an ingestible compositioncomprising ispaghula, colloidal silica, and an ingestible surfactant,the method comprising the step of blending the ispaghula with thecolloidal silica and the ingestible surfactant preferably without theemployment of any granulating agent.
 19. A method according to claim 18,of making an ingestible composition comprising ispaghula, colloidalsilica, and an ingestible surfactant, the method comprising the step ofblending the ispaghula with the colloidal silica and the ingestiblewithout the employment of polyvinyl pyrollidone.
 20. A method accordingto claim 14, of making an ingestible composition comprising ispaghula,colloidal silica, and an ingestible surfactant, the method comprisingthe step of blending the ispaghula with the colloidal silica and theingestible surfactant without the employment of any solvent; and withoutthe employment of any granulating agent.